FDA Registration
Active
🇺🇸 United States
Apex Modular Interface Acetabular Cup 20 Degree Liners
Reg #: 1226188
·
FEI: 3008342029
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- OMNIlifeScience, Inc.
- Registration Number
- 1226188
- FEI Number
- 3008342029
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 480 Paramount Dr
- City
- Raynham
- State
- MA
- ZIP
- 02767
- Country
- US
Regulatory Submissions
- 510(k) Number
- K092443
Owner / Operator
- Firm Name
- OMNI Life Science, Inc.
- Operator Number
- 9038042
- Address
- 480 Paramount Drive
- City
- Raynham
- State
- MA
- Postal Code
- 02767
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2012-03-21 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2012-03-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2012-03-21 |
Proprietary Names
Apex Modular Interface Acetabular Cup 20 Degree Liners
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility